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SPC, UK: NIZORAL Shampoo (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Nizoral 2% shampoo.

Qualitative and quantitative composition

Ketoconazole 2% w/w (each gram contains 20 mg). For a full list of excipients, see 6.1.

Pharmaceutical form

Pink viscous shampoo.

Therapeutic indications

Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff and seborrhoeic dermatitis. Treatment of tinea (pityriasis) ...

Posology and method of administration

For topical administration. Ketoconazole shampoo 2% is for use in adolescents and adults: Wash affected areas and leave for 3-5 minutes before rinsing. Usually, a palmful of shampoo suffices for one wash. ...

Contraindications

Known hypersensitivity to ketoconazole or any of the excipients.

Special warnings and precautions for use

In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral 2% shampoo, ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled ...

Overdose

In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

Pharmacodynamic properties

Pharmacotherapeutic group: Imidazole and triazole derivatives ATC Code: D01AC08 Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Its broad ...

Pharmacokinetic properties

Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral 2% shampoo on the scalp. Plasma levels were detected after topical administration of Nizoral 2% shampoo ...

Preclinical safety data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

List of excipients

Sodium lauryl ether sulfate Disodium monolauryl ether sulphosuccinate Coconut fatty acid diethanolamide Laurdimonium hydrolysed animal collagen Macrogol 120 methyl glucose dioleate Sodium chloride Concentrated ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Store below 25°C.

Nature and contents of container

High density polyethylene bottles, containing 120 ml shampoo.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK

Marketing authorization number(s)

PL 00242/0139

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 April 1988 Date of renewal of authorisation: 24 June 2008

Date of revision of the text

08 February 2019

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